The Drugs Controller General of India has granted approval for phase three bridging trials of the coronavirus vaccine, Sputnik Light, NDTV reported. The trials will assess the efficacy of the vaccine among Indian participants.
Sptunik Light is a single-dose version of Sputnik V, the coronavirus vaccine developed by Russia. In April, the Indian regulator’s Subject Expert Committee had approved Sputnik V for emergency use.
The subject expert committee has now granted permission to pharmaceutical company Dr Reddy’s Laboratories to conduct the trials.
Last year, the firm had partnered with the Russian Direct Investment Fund, the country’s sovereign wealth fund, to conduct phase three trials of the vaccine.
The committee said that the firm has presented data on safety and immunogenecity along with information on the longevity of the antibodies.
Sputnik Light could become the first single-dose vaccine to be used in India if it gets the emergency use approval.
The vaccine has an overall efficacy of 79.4% against Covid-19 and costs around Rs 730 per dose, the Russian government said in May.
Russia has approved the use of the Sputnik Light vaccine for beneficiaries above 60 years old.
The Sputnik V vaccine has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology.
The vaccine had shown a 91.6% efficacy in late-stage trials, according to results published in February. No serious adverse events were found to be linked with the vaccination.
However, the trial did not include efficacy data of the vaccine for new variants of the coronavirus.
On March 1, India received the first batch of the Sputnik V vaccine.
A total of 75,89,12,277 Covid-19 vaccine doses have been administered in India since the beginning of the immunisation drive in January, according to the Union health ministry’s data. On Tuesday alone, 61,15,690 vaccine doses were administered in the country.